Challenges in synthesis of real-world vaccine effects on meningococcal serogroup B disease for 4CMenB vaccine post-licensure effectiveness studies: A systematic review

•Systematic literature review of real-world 4CMenB vaccine effect outcomes was done.•Five identified studies showed large diversity, so no pooling of outcomes was done.•Vaccine estimates range for effectiveness was 59–94%, and for impact 31–75%.•Standardized tools to synthesize diverse real-world va...

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Bibliographic Details
Published in:Vaccine 2023-07, Vol.41 (30), p.4347-4358
Main Authors: Cinconze, Elisa, Rosillon, Dominique, Rappuoli, Rino, Vadivelu, Kumaran, Bekkat-Berkani, Rafik, Abbing-Karahagopian, Victoria
Format: Article
Language:English
Subjects:
Age
Effectiveness
Effectiveness studies
Estimates
Grey literature
Immunization
Licenses
Literature reviews
Meta-analysis
Observational studies
Real-world evidence
Schedules
Statistical analysis
Synthesis
Synthesis of effectiveness/impact
Systematic review
Vaccine efficacy
Vaccines
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Summary:•Systematic literature review of real-world 4CMenB vaccine effect outcomes was done.•Five identified studies showed large diversity, so no pooling of outcomes was done.•Vaccine estimates range for effectiveness was 59–94%, and for impact 31–75%.•Standardized tools to synthesize diverse real-world vaccine estimates are needed. Real-world studies on vaccine effects are diverse in terms of objectives, study setting and design, data type and scope, and analysis methods. In this review, we describe and discuss four-component meningococcal serogroup B vaccine (4CMenB vaccine, Bexsero) real-world studies with the aim of synthesizing their findings with application of standard methods. We performed a systematic literature review of all real-world studies on 4CMenB vaccine effects on meningococcal serogroup B disease, with no restriction for population age, vaccination schedule and/or type of vaccine effect evaluated (vaccine effectiveness [VE] and vaccine impact [VI] outcomes) published since its licensure in 2013 (from January 2014 until July 2021) in PubMed, Cochrane and the grey literature. We then aimed to synthesize the findings of the identified studies through application of standard synthesis methods. According to reported criteria we retrieved five studies presenting estimates on 4CMenB vaccine effectiveness and impact. These studies showed great diversity in population, vaccination schedule and analysis methods mainly due to diversity in vaccine strategies and recommendations in the study settings. Directed by this diversity, no quantitative pooling methods to synthesize findings could be applied; instead we descriptively assessed study methods. We report VE estimates ranging from 59% to 94% and VI estimates ranging from 31% to 75%, representing diverse age groups, vaccination schedules and analysis methods. Both vaccine outcomes showed real-life effectiveness of 4CMenB vaccine despite differences in study methodologies and vaccination strategies. Based on appraisal of study methods, we highlighted the need for an adapted tool which facilitates synthesis of heterogenic real-world vaccine studies when quantitative pooling methods are not applicable.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2023.05.025